Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-01 @ 10:22 PM
Study NCT ID:
NCT06505369
Status:
RECRUITING
Last Update Posted:
2024-07-17
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
Sponsor:
North Estonia Medical Centre
Organization:
Study Overview
Official Title:
A Phase II Study Measuring MRD Negativity After Bispecific T-cell Redirectors Talquetamab and Teclistamab Consolidation in Sequence as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TALTEC
Brief Summary:
This is Phase 2, open-label, multicentre, non-randomised study evaluating participants with newly diagnosed MM eligible for high-dose therapy. The goal of the study is to determine if consolidation with T-cell redirectors - Talquetamab and Teclistamab in sequence will improve the response depth: increase MRD negative CR rate.
Detailed Description:
A total of 50 transplant-eligible patients with newly diagnosed multiple myeloma in need of treatment will be enrolled.
The study consists of three phases: Induction, Consolidation, and Follow-up. Induction will consist of Dara-VRd and consolidation Part I will include talquetamab and Part II will include teclistamab.
Follow-up Phase After consolidation, treatment continues upon physician's choice: the options are ASCT with maintenance or only maintenance with lenalidomide.
Efficacy will be evaluated by serum/urine electrophoresis monthly; by serum/urine immunofixation, bone marrow morphology and flow cytometry when CR/sCR is suspected;
MRD will be evaluated by NGS ( at the level of 10-6) and FDG PET-CT ( by Deauville score) at various timepoints during induction, consolidation and follow-up.
Participants quality of life, symptoms, functional and general well-being will be captured using 3 PRO measures ( PRO-CTCAE, EORTC QLQ-C30, FACT-Cog).
The safety of study drugs will be assessed by physical examinations, vital signs, ECGs, clinical laboratory tests, neurologic examinations (including ICE scores), ECOG performance status, and AE monitoring according to NCI-CTCAE Version 5.0), grading of CRS and ICANS will be assessed based on ASTCT guidelines.
The study consists of three phases: Induction, Consolidation, and Follow-up. Induction will consist of Dara-VRd and consolidation Part I will include talquetamab and Part II will include teclistamab.
Follow-up Phase After consolidation, treatment continues upon physician's choice: the options are ASCT with maintenance or only maintenance with lenalidomide.
Efficacy will be evaluated by serum/urine electrophoresis monthly; by serum/urine immunofixation, bone marrow morphology and flow cytometry when CR/sCR is suspected;
MRD will be evaluated by NGS ( at the level of 10-6) and FDG PET-CT ( by Deauville score) at various timepoints during induction, consolidation and follow-up.
Participants quality of life, symptoms, functional and general well-being will be captured using 3 PRO measures ( PRO-CTCAE, EORTC QLQ-C30, FACT-Cog).
The safety of study drugs will be assessed by physical examinations, vital signs, ECGs, clinical laboratory tests, neurologic examinations (including ICE scores), ECOG performance status, and AE monitoring according to NCI-CTCAE Version 5.0), grading of CRS and ICANS will be assessed based on ASTCT guidelines.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: